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EC number: 606-946-6 | CAS number: 221640-14-8
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from February 2004 to April 2004
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 17 December 2001
- Deviations:
- yes
- Remarks:
- - according to the replaced version (1996) of the OECD TG 423 both sexes and a starting dose of 200 mg/kg bw were used
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- n.a.
- Molecular formula:
- n.a.
- IUPAC Name:
- n.a.
- Reference substance name:
- Carbamic acid [(1S)-,2-[(2-aminoethyl)amino]-1-[(4-ethoxyphenyl)methyl]ethyl]-,phenylmethyl ester, dihydrochloride (9Cl)
- IUPAC Name:
- Carbamic acid [(1S)-,2-[(2-aminoethyl)amino]-1-[(4-ethoxyphenyl)methyl]ethyl]-,phenylmethyl ester, dihydrochloride (9Cl)
- Reference substance name:
- benzyl[(2S)-1-[(2-aminoethyl)amino]-3-(4-ethoxyphenyl)propan-2-yl]carbamate dihydrochlorid
- EC Number:
- 606-946-6
- Cas Number:
- 221640-14-8
- Molecular formula:
- C21 H29 N3 O3 . 2 Cl H
- IUPAC Name:
- benzyl[(2S)-1-[(2-aminoethyl)amino]-3-(4-ethoxyphenyl)propan-2-yl]carbamate dihydrochlorid
- Test material form:
- solid
impurity 1
impurity 2
impurity 3
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: HAN: WIST (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source:Charles River, Berlin - Buch, Germany
- Mean weight at study initiation: 104-106 g (males) or 94-106 g (females)
- Housing: 1 animal per cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least >=7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 - 23
- rel. Humidity (%): 48 - 56
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 9 mg NaCl ad 1 ml Aqua p.i.
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 20 and 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg
- Doses:
- 200 mg/kg bw and 2000 mg/kg bw
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations were performed at five (200 mg/kg bw) or nine (2000 mg/kg bw) different time points on administration day and then once daily until day 14. Body weight was recorded weekly.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - < 500 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: The LD50 value was determined according to the replaced version (1996) of OECD test guideline 423. According to Regulation (EU) No. 1272/2008 the LD50 value is >300 and < 2000 mg/kg bw, corresponding to GHS Category 4
- Mortality:
- No mortality was observed after adiministration of 200 mg/kg bw in both sexes. After 2000 mg/kg bw all animals died between 4 hours after treatment and the following day of the study.
- Clinical signs:
- other: The main clinical findings after administration of 2000 mg/kg were increased sialorrhea and compulsive behavior five minutes after administration. Apathy, abnormal respiration and eyelid closure were also observed in the first hour after administration. L
- Gross pathology:
- Necropsy of the rats which died after administration of 2000 mg/kg revealed reddening or dark-red discoloration of the gastro-intestinal mucosa (small intestine). There were no abnormal necropsy findings in male and female rats dosed at 200 mg/kg bw.
Any other information on results incl. tables
clinical findings
Dose of test item | Sex | Findings | Numberof animals with findings/number of surviving animals | |||||||||
Day 1 (min after administration | ||||||||||||
5 | 15 | 30 | 60 | 120 | 180 | 210 | 240 | p.m. | Day 2-14 | |||
200 | M | Compulsive behaviour | 2/3 |
|
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|
Increased sialorrhea | 3/3 |
|
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|
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|
|
|
| ||
Without findings | 0/3 |
| 3/3 | 3/3 |
| 3/3 |
|
| 3/3 | 3/3 | ||
F | Compulsive behaviour | 1/3 |
|
|
|
|
|
|
|
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| |
Increased sialorrhea | 2/3 |
|
|
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|
|
|
|
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| ||
Without findings | 1/3 |
| 3/3 | 3/3 |
| 3/3 |
|
| 3/3 | 3/3 | ||
2000 | F | Increased sialorrhea | 3/3 |
|
|
|
|
|
|
|
|
|
Apathy, slight |
| 2/3 | 3/3 | 3/3 |
|
|
|
|
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| ||
Apathy, moderate |
|
|
|
| 3/3 | 3/3 | 1/3 | 1/2 |
|
| ||
Apathy, severe |
|
|
|
|
|
| 2/3 | 1/2 | 1/1 |
| ||
Prone, lateral or supine position, conscious |
|
|
|
|
|
| 1/3 |
|
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| ||
Compulsive behaviour | 3/3 | 1/3 |
|
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| ||
Gait spastic |
|
|
|
| 3/3 | 3/3 | 2/3 | 2/2 | 1/1 |
| ||
Respiration retarded |
| 3/3 | 3/3 | 3/3 | 3/3 | 3/3 | 3/3 | 2/2 | 1/1 |
| ||
Abnormal breathing sounds |
| 1/3 | 1/3 | 1/3 | 1/3 | 1/3 | 1/3 | 1/2 | 1/1 |
| ||
Eyelid closure |
| 1/3 | 2/3 | 3/3 | 3/3 | 3/3 | 3/3 | 2/2 | 1/1 |
| ||
Secretion, serous |
|
|
|
|
| 2/3 | 2/3 | 2/2 | 1/1 |
| ||
Fur ruffled |
|
|
|
| 3/3 | 3/3 | 3/3 | 2/2 | 1/1 |
| ||
Discolouration of eyes, dark reddish |
|
|
|
| 3/3 | 3/3 | 3/3 | 2/2 | 1/1 |
| ||
Discolouration of fore and hind limbs, bluish |
|
|
|
|
|
| 3/3 | 2/2 | 1/1 |
| ||
Without findings | 0/3 | 0/3 | 0/3 | 0/3 | 0/3 | 0/3 | 0/3 | 0/2 | 0/1 | 0/0 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The acute oral toxicity of the test item was moderate with an LD50 value of > 300 < 500 mg/kg bw in rats according to ANNEX 3b of OECD TG 423 (1996). All males and females dosed with 200 mg/kg bw survived. After 2000 mg/kg bw all animals died between 4 hours after treatment and the following day of the study. Clinical findings beyond 5 minutes after aopplication were limited to the 2000 mg/kg bw dose group. Body weight development was not affected. During autopsy reddening or dark-red discoloration of the gastro-intestinal mucosa (small intestine) were described for the animals which died after application of 2000 mg/kg
- Executive summary:
In an acute oral toxicity study according to OECD guideline 423 (1996), groups of, adult male and female WST (SPF) rats (3/sex) were given a single oral dose of Z-Triamine Dihydrochloride in 900 mg NaCl + 85 mg Myrj 53 ad 100 ml bidist. water at doses 2000 (only female) and 200 mg/kg bw (female and male) and observed for 14 days.
Oral LD50 Combined = > 300 mg/kg bw and < 2000 mg/kg bw (according to Regulation (EU) No. 1272/2008 (CLP))
Oral LD50 Combined = > 300 mg/kg bw and < 500 mg/kg bw (according to OECD Test Guideline 423 Annex 3c (1996))
All females died after oral ingestion of 2000 mg/kg bw. All males and females dosed with 200 mg/kg bw survived. Clinical findings were limited to the 2000 mg/kg bw dose group. Body weight development was not affected. Autopsy revealed reddening of the glandular mucosa of the stomach in only one animal which died after application of 2000 mg/kg and no compound-related or suspected compound-related findings in the two other animals which died or in the animals which were sacrificed at the end of the study.
Z-Triamine Dihydrochloride is of low Toxicity based on the LD50 in WIST (SPF) rats. The substance is classified according to Regulation (EU) No. 1272/2008 (CLP) and the Globally Harmonized System for Classification and Labelling of Chemicals (GHS) as Category 4 ‘harmful if swallowed’.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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